Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety of concurrent durvalumab with crt followed by durvalumab for chinese unresectable stage iii nsclc

Conditions: Unresectable Stage III NSCLC

Summary: this is a prospective, multi-center, single arm study assessing the efficacy and safety of durvalumab given concurrently with platinum-based crt (durvalumab + soc crt) in patients with locally advanced, unresectable nsclc (stage iii).

approximately 35 patients with locally advanced, unresectable nsclc (stage iii) who are eligible to receive platinum-based crt will be enrolled in and receive durvalumab + soc crt. patients with cr, partial response (pr), or stable disease (sd）based on investigator assessment at the 16-week tumor evaluation following completion of soc crt will continue to receive durvalumab as consolidation treatment. patients with recist 1.1-defined radiological progressive disease (pd) will proceed to follow-up.

Eligibility criteria:
inclusion criteria: * subjects with histologically or cytologically-documented nsclc * locally advanced, unresectable (stage iii) nsclc * world health organization (who) performance status 0-1 * at least one measurable lesion, not previously irradiated * must have a life expectancy of at least 12 weeks at randomization * adequate lung function: pre- or post-bronchodilator forced expiratory volume 1 of 1.0 l or \>40% predicted value and dlco \>30% predicted value * must provide an archived tumor tissue block(or at least 15 newly cut unstained slides)≤3 years old; if archived sample unavailable then must provide a recent(≤3 months) tumor biopsy. exclusion criteria: * mixed small-cell and nsclc histology * receipt of prior or current cancer treatment, including but not limited to, radiation therapy, investigational agents, chemotherapy, durvalumab and mabs. * prior exposure to immune-mediated therapy, including but not limited to, other anti- ctla-4, anti-pd-1, anti-pd-l1, and anti-pd-l2 antibodies. * patients whose radiation treatment plans are likely to encompass a volume of whole lung receiving ≥20 gy in total (v20) of more than 35% of lung volume * planned radiation cardiac dose v50\>25% * any medical contraindication of platinum-based doublet chemotherapy as listed in the local labelling or known allergy/hypersensitivity to investigational product and/or its excipients * history of the following: allogeneic organ transplantation, active or prior autoimmune or inflammatory disorders, another primary malignancy, leptomeningeal carcinomatosis, active primary immunodeficiency * uncontrolled intercurrent illness or active infection
a 52-week study of bicifadine in patients with chronic neuropathic pain associated with diabetic peripheral neuropathy

Conditions: Chronic Peripheral Neuropathy Pain in Diabetics

Summary: this study is to evaluate the long-term efficacy and safety of two dosages of bicifadine sr (600 mg/day and 1200 mg/day) for up to 52 weeks in reducing chronic peripheral neuropathy pain due to diabetes in adult outpatients.


Eligibility criteria:
inclusion criteria: * male or female * 18 years or older * diagnosis of type 1 or type 2 non-insulin dependent diabetes mellitus * chronic bilateral pain due to diabetic neuropathy, pain for at least six months. * primary pain is located in the feet. * subject participated in and completed the xtl 07-001 clinical trial. contact site for additional information. exclusion criteria: * symptoms of other painful conditions * presence of amputations other than toes * clinically significant psychiatric or other neuropsychological disorder * use of certain medications * clinically important other diseases * pregnancy * history of alcohol or narcotic abuse within two years. contact site for additional information.
vivity insight: a study of patient satisfaction and visual performance

Conditions: Cataract

Summary: this will be a single arm, open-label, prospective study of patient-reported outcomes of patients with bilateral implantation of the vivity or vivity toric implant.

existing diffractive extended depth of focus (edof) lenses provide two adjacent "zones" of uncorrected vision (distance and intermediate or intermediate and near) but have a track record of frequent patient dissatisfaction because of unwanted visual side effects, "spider webs" or haloes. the vivity non-diffractive edof lens offers this same range ofvision with contrast sensitivity similar to a monofocal lens, which suggests fewer side effects will be encountered in clinical practice. this study is designed to measure postoperative patient-reported outcomes with this new lens implant. previous studies we have conducted on the bilateral restor 3.0, restor with activefocus 2.5 (mixed with 3.0 and alone with mini-monovision) have shown high satisfaction, spectacle independence, and acceptable glare and halo profiles using a validated questionnaire instrument developed by mdbackline, inc. the postoperative portions of this study will be designed to mirror those previous studies using the same instrument. all subjects will receive the vivity or vivity toric implant binocularly with a target of plano sphere.

Eligibility criteria:
inclusion criteria: * patients with cataract and otherwise healthy eyes, not exhibiting any significant ocular morbidity that would be expected to influence outcome measures. * patients implanted with vivity or vivity toric lenses bilaterally within 6 months of the survey administration. * patients whose postoperative manifest refraction at the time of the survey is within ± 0.5 d sphere and ≤0.75 d of cylindrical refraction. * patients who have given consent to participate in the survey. exclusion criteria: * patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect their satisfaction with surgery. * patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered iol, cystoid macular edema, etc.) that would, the judgement of the investigator, influence the outcome measures of the study. * patients with previous refractive surgery within the past 6 months prior to cataract surgery. * patients with \> grade 1 posterior capsule opacity at their last visit. * patients who do not meet the refractive endpoints described in the inclusion criteria.
diagnosing malfunctioning hydrocephalic shunt valves with a flow sensor

Conditions: Hydrocephalus

Summary: the study hypothesis is that a transit-time ultrasonic sensor can help doctors diagnose a malfunctioning shunt valve. the study will simulate an implanted shunt flow monitoring system by placing the flow sensor and a programmable shunt valve into the patient's extra-ventricular drainage line. flow will be measured as the doctor raises/lowers the drainage bag to simulate the patient sitting up/lying down. the doctor will simulate a malfunctioning shunt by changing the valve's pressure release settings for each cycle of raising/lowering the bag. by monitoring shunt flow during these changes, the doctors hope to develop new ways to diagnose malfunctioning shunt valves when implanted shunt flow monitors become available.


Eligibility criteria:
inclusion criteria: * diagnosed with hydrocephalus * newborn through age 20 * external ventriculostomy with an extra-ventricular drainage system installed exclusion criteria: * not diagnosed with hydrocephalus * older than age 20 * no external ventriculostomy with an extra-ventricular drainage system installed

Keywords: hydrocephalus shunt dysfunction shunt flow
effect of hcq on anxa5 resistance assay in antiphospholipid (apl) positive patients with and without systemic lupus erythematosus (sle)

Conditions: Antiphospholipid Syndrome; Thrombophilia Due to Antiphospholipid Antibody; Systemic Lupus Erythematosus

Summary: this 12 week study will observe patients with and without systemic lupus erythematosus who have persistent antiphospholipid antibodies in the blood who are starting a medicine called hydroxychloroquine. it will measure if these patients have a change in a blood test called the annexin a5 resistance assay over that 12 week period.

antiphospholipid syndrome (aps) is an autoimmune disorder of blood clotting and pregnancy loss. it is associated with proteins called antiphospholipid antibodies (apl) in the blood. blood clotting in this disease occurs for several reasons; one reason involves the interaction of apl with another protein found on the surface of the cells that line blood vessels (endothelial cells). this protein, called annexin a5 (anxa5), forms a shield over the surface of these cells. the anxa5 resistance assay is a blood test that can detect when there is a problem with the protective anxa5 shield on endothelial cell surfaces. this 12 week study will observe patients with persistent apl in the blood who are starting a medicine called hydroxychloroquine (hcq). the primary goal of the study is to compare results of the anxa5 resistance assay from patients before they start taking hcq and after they have taken it for 12 weeks to see if the results of the blood test change. our secondary goal is to measure a variety of other blood tests before and after patients have started taking hcq; these tests include d-dimer, activated protein c (apc) resistance, and apl titers/status (la test, acl elisa, aß2gpi elisa, and anti-domain-i ß2gpi elisa).

Eligibility criteria:
inclusion criteria: * age 18 to 65 * new hcq (200-400 mg/day) treatment (for all but 5 of 10 control subjects - see below) * persistently positive apl selected exclusion criteria: * steroid use greater than or equal to the equivalent of prednisone 0.5 mg/kg/day at the time of enrollment * heparin use at the time of enrollment * any immunosuppressive drug use within 3 months prior to screening * hcq use within the past 6 months prior to screening visit * another antimalarial agent treatment, * pregnant women, minors, mentally disabled, prisoners * acute thrombosis within 2 weeks prior to screening

Keywords: antiphospholipid syndrome antiphospholipid antibodies systemic lupus erythematosus annexin a5 and annexin a5 resistance assay
4sc-201 (resminostat) and sorafenib in advanced hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: the purpose of the study is to determine whether 4sc-201 alone or in combination with sorafenib is effective and safe in the treatment of hepatocellular carcinoma in patients refractory to sorafenib monotherapy.


Eligibility criteria:
main inclusion criteria: * advanced stage hepatocellular carcinoma * patients exhibiting progressive disease under sorafenib treatment * child-pugh class a and b. only patients with child-pugh index class b of not more than 7 will be included * ecog performance status 0, 1 or 2 * precedent first-line treatment with sorafenib minimum continuous dosing of 400 mg per day for at least 8 weeks main exclusion criteria: * previous or concurrent cancer that is distinct in primary site or histology from hcc, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (ta, tis and t1) - any cancer curatively treated \> 3 years prior to entry is permitted * renal failure requiring hemo- or peritoneal dialysis * known central nervous system (cns) tumors including symptomatic brain metastasis * child-pugh index class b in combination with more than slight ascites or hepatic encephalopathy \> grade i * pregnant or breastfeeding women * sorafenib intolerance * major surgery within the last 4 weeks

Keywords: hepatocellular carcinoma sorafenib hdac 4sc-201 phase ii resminostat
spaeth/richman contrast sensitivity test

Conditions: Glaucoma

Summary: the spaeth-richman contrast sensitivity (sparcs) test is a new method of assessing contrast sensitivity. the test, another way to measure vision, is performed on any standard computer with internet access. patients will be tested with sparcs and with the standard pelli-robson contrast test.

contrast sensitivity is another way to test vision. it uses black on a white background and minimally decreases the black (grey) until it blends with the white. the least amount of contrast (faint grey) seen translates into amount of vision. this new method of determining contrast sensitivity uses black and white vertical bars and does not require recognizing letters in the alphabet. it tests various areas of the visual field and central vision. the test takes approximately 3 minutes per eye. pelli-robson is a commonly used contrast sensitivity test that uses black letters on a white background. the letter size stays the same, only the amount of black changes, becoming greyer, making letters hard to see. the test takes approximately 1 minute per eye. hypothesis: a method of determining contrast sensitivity that does not require letter recognition (as does the pelli-robson test) eliminates the barriers of literacy and pattern recognition, to permit a more valid determination of contrast sensitivity. patients will perform sparcs and pelli-robson twice; once each with two separate observers for reproducibility and intra-observer reliability. the order of testing will be randomized to sparcs, pelli, pelli, sparcs or pelli, sparcs, sparcs, pelli.

Eligibility criteria:
inclusion criteria: * 18 yrs of age and older * able to provide fully informed consent 70 controls (patients with no ocular disease affecting visual acuity or visual function), 10 from each decade of life: 20-30, 30-40, 40-50, 50-60, 60-70, 70-80, 80+. 105 patients with ocular hypertension or any type of glaucoma (15 subjects per age decade). glaucoma patients will not have macular degeneration or visual acuity affected by any function other than glaucoma. 40 patients with macular degeneration: 10 with visual acuity 20/40 or better, 10 with visual acuity between 20/40 and 20/60, 10between 20/100 and 20/400, and 10 with 20/400 or worse. 40 patients with cataracts: 10 with lens opacity 1+nuclear sclerosis, 10 with 2 + nuclear sclerosis, 10 with 3 + nuclear sclerosis, 10 with 4 + nuclear sclerosis. 60 patients with refractive error: 10 with myopia -5 diopters or greater, 10 with myopia between -5 and -2.5, 10 with myopia between -2.5 and -0.5, 10 with myopia between -0.5 and 0.5, 10 with myopia between 0.5 and 2.5, and 10 with myopia \> 2.5. exclusion criteria: * any other diseases affecting visual acuity

Keywords: contrast sensitivity pelli-robson test
the effect of post-cesarean section acupressure on the severity of pain and first mobilization distance

Conditions: Pain; Mobilization

Summary: this randomized controlled trial evaluates the effect of acupressure application on cesareans' pain and the number of steps in the first mobilization. this study hypothesizes that acupressure reduces pain and improves number of steps.

methods: in the study, 64 cesareans will randomly assigned to acupressure and placebo acupressure groups. to the acupressure group (n = 32), an average of 15 minutes will be applied to the li4 (liver), p6 (pericardium) and the sanyinjia points on the splenic meridian (sp6) located on the inner side of the lower leg, four fingers above the ankle and behind the tibia. in the placebo acupressure group (n = 32), the points 1.5 cm away from the li4, p6 and sp6 points (four points in total) will be applied for an average of 15 minutes. the primary outcome of the research is the effect of acupressure on the pain of cesareans. the secondary outcome of the study is to determine the effect of acupressure on the number of steps. the pain will be collected before and 1 minute, 2nd and 4th hour after acupressure and placebo acupressure administration. the number of steps will be collected 4th hour after acupressure and placebo acupressure administration.

Eligibility criteria:
inclusion criteria: * being conscious, * the mother tongue is turkish, * to be oriented and cooperative, * be between 18-45 years old, * to voluntarily agree to participate in the study (signing the informed consent form), * repeated cesarean section, * cesarean section under spinal anesthesia, * not having a risky pregnancy (preeclampsia, gestational diabetes etc.), * no health problems of the fetus, * to have given birth by cesarean section between 37-40 weeks, * to be in the second hour of the postpartum period, * not receiving post-op patient-controlled analgesia, * not to have smoked or used alcohol during pregnancy, * no complications in the mother and/or newborn after cesarean section, * no sensitivity in the area where acupressure will be applied, * absence of any systemic or psychiatric diagnosis, * absence of active covid-19 infection. exclusion criteria: * lack of consciousness, * the mother tongue is not turkish, * not oriented and cooperative, * not to be between the ages of 18-45, * refusal to voluntarily participate in the study (those who did not sign the informed consent form), * normal birth or cesarean delivery under general anesthesia, * cesarean delivery due to the risk of deterioration of maternal or fetal health, * not having had a risky pregnancy (preeclampsia, gestational diabetes, etc.), * not giving birth outside 37-40 weeks and by cesarean section, * not in the second hour of the postpartum period, * receiving post-op patient-controlled analgesia, * to have used cigarettes and alcohol during pregnancy, * sensitivity in the area where acupressure will be applied, * presence of any systemic or psychiatric diagnosis, * active covid-19 infection.

Keywords: post-cesarean acupressure pain step mobilization
methylphenidate for treating children with adhd and tourette syndrome

Conditions: Attention Deficit Disorder With Hyperactivity; Tourette Syndrome

Summary: this study will evaluate the safety and effectiveness of methylphenidate in treating attention deficit hyperactivity disorder in children with both attention deficit hyperactivity disorder and tourette syndrome.

tourette syndrome is a neurological disorder that is characterized by repetitive, involuntary movements and vocalizations called tics. many children with tourette syndrome also have attention deficit hyperactivity disorder (adhd), which is one of the most common childhood mental disorders. symptoms of adhd usually include impulsiveness, inattention, and hyperactivity. adhd is commonly treated with a stimulant medication, such as methylphenidate. it is under debate, however, whether using stimulants in children with tourette syndrome exacerbates tics associated with the disorder. this study will evaluate the safety and effectiveness of methylphenidate in treating adhd in children who have both adhd and tourette syndrome. participants in this 6-week, double blind study will receive three doses of methylphenidate over the course of the study. each dose will be taken twice daily, approximately 3.5 hours apart, for 2 weeks. medication will be dispensed at study visits, which will occur once every 2 weeks. at each study visit, participants will take a dose of the medication. about an hour after ingesting the medication, they will be observed in a classroom setting by study physicians. participants will then complete a continuous performance test, which will measure their voluntary attention levels. the following will be assessed at study visits: adhd symptoms; oppositional and aggressive behavior; frequency and severity of tics and obsessive compulsive disorder symptoms; rebound tic exacerbation; effects of methylphenidate on tic-related problems with self-esteem, family life, academic and social performance, and overall tic severity; anxiety and mood symptoms; and adverse drug reactions. parents and teachers will also complete assessments of participants' behavior on 2 days of each week for the duration of the study.

Eligibility criteria:
inclusion criteria: * diagnosis of adhd or adhd plus tourette syndrome exclusion criteria: * determined to be dangerous to self or others * scores less than 70 on an iq test * any seizure disorder, major organic brain dysfunction, major medical illness, major mood disorder, psychosis, pervasive developmental disorder, or peripheral sensory loss * any condition that may make use of methylphenidate unsafe

Keywords: adhd
a trial with subcutaneous immunotherapy (scit) in patients with rhinoconjunctivitis sensitized to olea europaea and phleum pratense

Conditions: Rhinoconjuntivitis

Summary: the study was designed according to the draft of allergenic product regulation published by spanish regulatory agency. the aim of the study is to evaluate the safety and tolerability of subcutaneous immunotherapy with polimerized (100/100) mixture of pollens: olea europaea and phleum pratense in patients with rhinoconjunctivitis with or without associated mild asthma. in addition, surrogate efficacy parameters will be evaluated: immunoglobulin level changes and skin reactivity.


Eligibility criteria:
inclusion criteria: 1. patients must sign the informed consent form. 2. patients must be between 18 and 60 years of age. 3. patients with seasonal allergic rhinoconjunctivitis produced by phleum pratense and olea europaea during at least 2 years prior to participating in the study. although the pathology being studied is allergic rhinoconjunctivitis, patients who have concomitant mild or moderate asthma may be included. 4. patients who have had a skin prick test result ≥ 3 mm in diameter against phleum pratense and olea europaea. 5. patients who have specific ige ≥ class 2 (cap/phadia) to phleum pratense and olea europaea. 6. patients will preferably be polysensitized to phleum pratense. polysensitized patients to otherallergenic sources may only be included in the study if their other sensitizations are produced by: 1. overlapping seasonal pollens which are cross-reactive with phleum pratense and olea europaea. 2. pollens whose seasons do not overlap with phleum pratense or olea europaea and which are not expected to produce symptoms during the study period. 3. other allergens which are not expected to produce symptoms during the study period. 7. women of child-bearing potential must have a negative urine pregnancy test at the time they begin the study. 8. furthermore, women of child-bearing potential must agree to use adequate contraceptive methods during this study if they are sexually active. exclusion criteria: 1. patients who received immunotherapy in the previous 5 years for phleum pratense and olea europaea or for any allergen with cross reactivity or patients that are currently receiving immunotherapy for any allergen. 2. patients with severe asthma or forzed expiratoy volumen in 1 second fev1\< 70% even if the are pharmacologically controlled . 3. patients with: immunological, cardiac, renal or hepatic illnesses or any other medical condition that the investigator deems relevant so as to interfere with the study. 4. patients with a previous history of anaphylaxis 5. patients with chronic urticaria, 6. patients with moderate to severe atopic dermatitis 7. patients who have participated in another clinical trial within 3 month prior to enrolment. 8. patients under treatment with tricyclic antidepressives, phenothiazines , β- blockers, or angiotensin converting enzyme inhibitors (acei) 9. female patients who are pregnant or breast-feeding 10. patient who does not attend the visits

Keywords: allergy immunotherapy scit
study evaluating the safety and efficacy of ptx-022 (qtorin sirolimus) in the treatment of microcystic lymphatic malformations

Conditions: Microcystic Lymphatic Malformation

Summary: this study evaluates the safety and efficacy of ptx-022 (sirolimus) topical gel 3.9% w/w in the treatment of microcystic lymphatic malformations. the participant will receive 3 months of ptx-022 treatment by the end of the study.


Eligibility criteria:
inclusion criteria: * participants must be 6 years or older * diagnosed with microcystic lymphatic malformations * able and willing to comply with all protocol-required activities * willing and able to provide written informed consent exclusion criteria: * any significant concurrent condition that could adversely affect participation. * any history of allergy or hypersensitivity to sirolimus, or sirolimus-like medications or to ptx-022 * patient's deemed by the investigator as unwilling or unable to remain compliant with all tests and procedures, including adherence to study drug administration and other protocol-required activities.